The clean room GMP requirements for raw materials are mainly three processes of fine, baking and packaging. “Fine” includes processes such as fine filtration, crystallization, separation and inspection. “Bake” includes processes such as drying, crushing, mixing, and inspection. "Package" includes the processing and packaging of packaging materials; drying as much as possible using dry and mixed powder equipment, the air used for drying should be purified to achieve the same level of cleanliness as the production environment, the tail gas needs to be collected, dusted After discharge; smashing and sieving, there should be local dust or dust suction devices; it should be noted that the direct contact packaging materials should be cleaned and disinfected according to appropriate methods. The inner packaging materials used for raw materials should be washed with filtered water for injection and within 4H. Sterilization, used within 24H, stored in the storage room of the same cleanliness level as the packaging; when there is a batch production, pay attention to clearing the field.
When the aseptic bulk drug is dried, the door of the oven inlet should be opened to the clean workshop, the air inlet should also be opened indoors and have a high-efficiency air filter, and the oven inlet of the non-sterile bulk drug should also be equipped with sub-high efficiency air filtration. In order to prevent microbial contamination, the vents of purified water, water for injection and storage tanks should be equipped with high-efficiency filters that do not fall off the fibers; in the clean area, the use of materials and utensils that emit dust particles or fibers should be avoided in the clean area. The number should be controlled to a low level; materials containing asbestos should not be used as the filter medium. Zhongjing Global Purification can provide consulting, planning, design, quotation, construction, decoration and other supporting services for the clean workshop.
The “three wastes” produced in the production process shall comply with the discharge standards stipulated by the state; when using open equipment or opening equipment, there shall be measures to avoid pollution; when the quality inspection of intermediate products has a cross-effect on the production environment, the inspection sites shall not It should be set in the production area; when changing the variety, the equipment must be thoroughly cleaned. When the same equipment is continuously produced, if there are residues that affect the quality of the product, the equipment should be thoroughly cleaned when the batch is changed.